510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PNJClass III

Leadless Pacemaker

21 CFR 870.3610 / Cardiovascular
FDA source (opens on fda.gov)

PNJ is the FDA product code for Leadless Pacemaker, a class III device type, regulated under 21 CFR 870.3610. FDA's definition for this code reads: "To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary". As of , FDA records hold no 510(k) clearances under this code and 6 recalls.

Classification record

Product code
PNJ
Device name
Leadless Pacemaker
FDA definition
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Regulation
21 CFR 870.3610
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
6

Companies listing this code with FDA

Companies whose registered establishments list this code